Generic Name: None — Brand Names: (1) Hiftop HD — (2) Prona HD

Recalling firm: Name of Manufacturer and Distributor: Shinshin Yakuhin Kogyo Co., Ltd. — Address of Manufacturer and Distributor: 324 Imaichi, Toyama City, Toyama Prefecture — Type of License: Type II...
Product: Lot: （１）ヒフトップＨＤロット容量数量出荷時期Ｅ２０１３０ｍＬ１０，２４９２０２２年１０月〜２０２３年４月Ｂ３０１３０ｍＬ１０，１２６２０２３年４月〜２０２３年７月Ｆ３０１３０ｍＬ１０，２５７２０２３年７月〜２０２４年２月Ｋ３０１３０ｍＬ１０，２６９２０２４年２月〜２０２４年５月Ｃ４０１３０ｍＬ１０，２９６２０２４年５月〜２０２４年１２月Ｉ４０１３０ｍＬ１０，２５８２０２４年１２月〜２０２５年４月Ｃ５０１３０ｍＬ１０，２６４２０２５年４月〜２０２５年５月（２）プロナＨＤロット容量数量出荷時期Ｊ２０１３０ｍＬ１０，２６８２０２３年１月〜２０２３年１０月Ｆ３０１３０ｍＬ１０，２７０２０２３年１１月〜２０２４年８月Ｃ４０１３０ｍＬ１０，３９８２０２４年８月〜２０２５年４月Ａ５０１３０ｍＬ１０，２８１２０２５年４月〜２０２５年５月. Use: 湿疹、皮膚炎、あせも、かぶれ、かゆみ、虫さされ、じんましん. Health hazards: プレドニゾロン吉草酸エステル酢酸エステルの含量の低下により、有効性の低下が生じる可能性はありますが、重篤な健康被害が発生する恐れはないと考えております。また、現在までに本件に起因すると考えられる健康被害の報告は受けておりません。
Reason: During the 36-month stability monitoring of this product (shelf life), the content of the active ingredient, prednisolone valerate acetate, deviated slightly from the lower limit of the approved specification. Since a decrease in content was also observed in other lots, we cannot rule out the possibility that the content may deviate from the approved specification within the expiration date; therefore, we have decided to recall all lots within the expiration date.
Classification: Class II
Category: drug recall
Country: Japan
Agency: PMDA-DRUG
Status: Ongoing

Recall details on Nibble Recalls: https://trynibble.app/recalls/3ce0a256-e6e6-49fd-957d-29a819676af8